A Feasibility and Usability Study of a Nursing Orchestrated, Customized 3 Dimensional Virtual Reality Environment in Children With Hemophilia Undergoing Routine Intravenous Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Nurse Orchestrated Virtual Reality Distraction
研究概览
简要总结
Children with hemophilia are exposed to intravenous (IV) procedures that cause pain/anxiety and distraction methods can be employed to improve the patient experience. Three-dimensional virtual reality (VR) environments can reduce distress related to procedures. To be utilized in a clinical setting, however, these devices must address infection control concerns and fit pediatric patients. Additionally, for use in hemophilia care, environments should encourage a subject to keep their hands/arms still to facilitate procedures. Nursing orchestration of the VR environment via an iPad dashboard has the potential to increase feasibility and acceptance by patients, families and providers of the VR experience without disrupting routine clinical care.
详细描述
Patients with hemophilia A and B (HA/HB) are frequently treated with IV infusions of clotting factor concentrates to treat and prevent bleeding. Additionally they typically have at least yearly IV laboratory assessments. Pain and anxiety with needle related procedures particularly in children with hemophilia can lead to development of needle phobia, treatment avoidance and poor adherence to treatment regimens. Conventional virtual reality (VR) environments have been shown to reduce pain/anxiety in pediatric populations however in a clinical setting children with hemophilia have specific VR design needs that have not been addressed. Certain issues related to VR environments are related to the pediatric age range. These include the size and weight of VR headsets, the ease of donning and doffing headsets, and degree of engagement with VR environments. Hemophilia specific issues include the need for the VR experience to limit movement of the hands/arms to facilitate IV procedures, customization to prevent boredom/disengagement from repeated use and ability of clinical staff to trigger events via an orchestration dashboard that occur for the patients benefit at key times during IV procedures. Lastly, there are issues related to integration into a clinical setting. These include ability to integrate into clinical care without adversely affecting clinic flow, and infection control issues related to headset design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Diagnosed with Hemophilia A or B
- •Male or female, aged >6 years to <19 years
- •Subject and caregiver able to understand and speak English
- •Being seen for routine comprehensive hemophilia care visits during which an IV procedure is planned as standard of care.
排除标准
- •Inability to use the VR equipment (ie visual, cognitive or hearing impairment that would preclude engagement with the VR environment)
- •History of motion sickness as reported by patient or caregiver
- •History of poorly controlled seizures as reported by patient or caregiver
研究组 & 干预措施
Virtual Reality Distraction
This intervention consists of a disposable virtual reality headset which will enable the use of virtual reality in clinic through the commodity hardware iPod Touch. An additional piece of software on an iPad will allow clinical staff to act as an orchestrator and trigger events that occur for the patient's benefit in the virtual reality environment. The mechanism for the dashboard will be dashboard software running on an iPad tablet that will wirelessly communicate to the iPod Touch the patient is wearing. A study timer will be incorporated into the orchestration dashboard. The VAS/FACES scale will be incorporated into the iPad used for orchestration.
干预措施: Virtual Reality Distraction (Other)
Standard of Care Distraction
This intervention consists of a two dimensional distraction (ie TV/tablet) as well as verbal distraction (ie singing/talking/music) will be allowed by caregivers, nurses and phlebotomy staff but will not qualified or quantified. IV procedures will proceed in Groups A and B. At the completion of the IV procedure the nurse orchestrator will stop the procedure timer. The Subject, Guardian and Nurse orchestrator will complete the Final VAS/FACES assessment on the iPad.
干预措施: Standard of Care Distraction (Other)
结局指标
主要结局
Nurse Orchestrated Virtual Reality Distraction
时间窗: Twelve months
The primary outcome of feasibility was assessed using a surrogate marker of feasibility which was duration of the IV procedure measured in minutes in both study arms. Procedure time was the length of time from the moment a patient was positioned for the procedure to the completion of the procedure. The study timer was incorporated in the study IPAD and timing was performed by the nurse orchestrator.
Standard of Care Distraction
时间窗: Twelve months
The primary outcome of feasibility was assessed using a surrogate marker of feasibility which was duration of the IV procedure measured in minutes in both study arms. Procedure time was the length of time from the moment a patient was positioned for the procedure to the completion of the procedure. The study timer was incorporated in the study IPAD and timing was performed by the nurse orchestrator.
次要结局
- Effectiveness of the distraction technique(Twelve months)
- Usability and Likeability(Twelve months)